Mindfulness-Based Intervention for Adolescents With Chronic Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2025-05-23

Brief Summary

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The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

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Detailed Description

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Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.

Conditions

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Migraine Migraine in Adolescence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BREATHE-Migraine

Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.

Group Type EXPERIMENTAL

BREATHE-Migraine

Intervention Type BEHAVIORAL

The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine.

Interventions

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BREATHE-Migraine

The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 13 to 18 years
* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
* Patient report of \>= 8 headache days per month
* PedMIDAS Score of \> 10 (at least mild headache-related disability)